Apparatus and method for guide-wire based advancement of a rotation assembly

ABSTRACT

Apparatus is provided, comprising (1) a guide member, (2) a tissue-adjustment mechanism having (a) an upper surface and a lower surface, (b) at least one first opening at the upper surface, (c) at least one second opening at the lower surface, and (4) a channel extending between the first and second openings, the channel facilitating advancement of the tissue-adjustment mechanism along the guide member; and (3) at least one repair chord coupled at a first portion thereof to the tissue-adjustment mechanism and having at least a first end that is configured to be coupled to a portion of tissue of a patient, the repair chord being configured to adjust a distance between the portion of tissue and the tissue-adjustment mechanism, in response to adjustment of the repair chord by the tissue-adjustment mechanism. Other embodiments are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation-in-part of:

(a) International Application PCT/IL2011/000446 to Miller et al.,entitled “Apparatus and method for guide-wire based advancement of arotation assembly,” filed on Jun. 6, 2011 (which published asWO/2011/154942);

(b) U.S. patent application Ser. No. 12/795,192 to Miller et al.,entitled “A method for guide-wire based advancement of a rotationassembly,” filed on Jun. 7, 2010 (which published as US 2011/0301698);and

(c) U.S. patent application Ser. No. 12/795,026 to Miller et al.,entitled “Apparatus for guide-wire based advancement of a rotationassembly,” filed on Jun. 7, 2010 (which published as US 2011/0106245),which is a continuation-in-part of U.S. patent application Ser. No.12/608,316 to Miller et al., entitled, “Tissue anchor for annuloplastydevice,” filed on Oct. 29, 2009 (now U.S. Pat. No. 8,277,502).

All of these applications are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates in general to valve and chordeae tendineaerepair. More specifically, the present invention relates to repair of anatrioventricular valve and associated chordeae tendineae of a patient.

BACKGROUND

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

Chronic or acute left ventricular dilatation can lead to papillarymuscle displacement with increased leaflet tethering due to tension onchordae tendineae, as well as annular dilatation.

SUMMARY OF THE INVENTION

In some applications of the present invention, apparatus is providedcomprising an implant comprising one or more primary adjustable repairchords and an adjustment mechanism that is configured to adjust atension of the one or more adjustable repair chords and that is slidablealong a guide wire toward an implantation site. Additionally, theapparatus comprises a first tissue-engaging element (e.g., a tissueanchor) that comprises one or more docking stations. Furtheradditionally, in accordance with some applications of the presentinvention, a method is provided for implanting such apparatus. Arespective guide wire is reversibly coupled to each one of the dockingstations. The adjustment mechanism is slidable along the guide wiretoward one of the one or more docking stations, and is coupled to thetissue-engaging element via the docking station. Thus, the dockingstation is a coupling element that provides coupling between two otherelements (in this case, between adjustment mechanism and thetissue-engaging element.)

The repair chord comprises a flexible, longitudinal member (e.g.,sutures or wires). The repair chord is coupled at a distal portionthereof to the adjustment mechanism. In some applications, the repairchord functions as artificial chordae tendineae. In other applications,the repair chord is used to adjust a distance between two portions ofthe ventricular wall. For some applications, the repair chord is coupledat a proximal portion thereof to a second tissue-engaging element (e.g.,a tissue anchor which penetrates or clips a portion of tissue).

For other applications, the repair chord comprises a cord that isdisposed within at least a portion of an annuloplasty ring structure(e.g., a full annuloplasty ring or a partial annuloplasty ring). Forsuch applications, the annuloplasty ring structure comprises theadjustment mechanism that is coupled to the repair cord. Theannuloplasty ring structure is slidable along the guide wire toward oneof the one or more docking stations, and is coupled to thetissue-engaging element via the docking station. It is to be noted thatthe annuloplasty ring structure may be provided independently of theadjustment mechanism and the repair chord. For such applications, theannuloplasty ring structure is slidable along the guide wire toward oneof the one or more docking stations, and is coupled to thetissue-engaging element via the docking station.

For yet other applications, a prosthetic heart valve and/or a supportfor the prosthetic heart valve is slidable along the guide wire towardone of the one or more docking stations, and is coupled to thetissue-engaging element via the docking station.

Thus, the tissue-engaging element and the docking station are used tofacilitate implantation of an implant such as cardiac valve implants,namely annuloplasty ring structures, prosthetic valves, and/or apparatusfor receiving a prosthetic valve (e.g., a docking station or a supportfor receiving the prosthetic valve).

Typically, during a transcatheter procedure, the first tissue-engagingelement is coupled to a first portion of tissue at a first implantationsite in a heart of a patient. The adjustment mechanism is then slidalong the guide wire and toward the first tissue-engaging element at thefirst implantation site. The proximal portion of the repair chord isthen coupled via the second tissue-engaging element to a second portionof tissue at a second implantation site. Following the coupling of thesecond tissue-engaging element to the second implantation site, theadjustment mechanism is further slid distally toward the firsttissue-engaging element and is then coupled to the first tissue-engagingelement via the one or more docking stations on the firsttissue-engaging element. Following the coupling of the adjustmentmechanism to the second tissue-engaging element, a length and tension ofthe repair chord is then adjusted in order to adjust a distance betweenthe first and second implantation sites. For applications in which therepair chord functions as an artificial chordea tendinea, the adjustmentof the length and tension of the repair chord draws the leafletstogether, and/or pulls the leaflet down toward the first implantationsite to repair the valve.

In some applications of the present invention, the adjustment mechanismcomprises a spool assembly which adjusts a degree of tension of therepair chord. The spool assembly comprises a housing, which houses aspool to which a distal portion of the repair chord is coupled.

For applications in which the repair chord is coupled to two respectiveportions of the ventricular wall, the two portions are drawn together,thereby restoring the dimensions of the heart wall to physiologicaldimensions, and drawing the leaflets toward one another.

In some applications of the present invention, the adjustment mechanismcomprises a reversible locking mechanism which facilitates bidirectionalrotation of the spool in order to effect both tensioning and relaxing ofthe repair chord. That is, the spool is wound in one direction in orderto tighten the repair chord, and in an opposite direction in order toslacken the repair chord. Thus, the spool adjustment mechanismfacilitates bidirectional adjustment of the repair chord.

In some applications of the present invention, the adjustable repairchord is implanted during an open-heart or minimally-invasive procedure.In these applications, the delivery tool comprises a handle and amultilumen shaft that is coupled at a distal end thereof to theadjustment mechanism. The delivery tool functions to advance theadjustment mechanism to the first portion of tissue, implant theadjustment mechanism at the first portion of tissue, and effectadjustment of the repair chord by effecting rotation of the spool. Forapplications in which the repair chord functions as an artificialchordea tendinea, prior to implantation of the adjustment mechanism, thedistal portion of the delivery tool and the adjustment mechanism coupledthereto are advanced between the leaflets of the atrioventricular valveand into the ventricle toward the first portion of tissue. The incisionmade in the heart is then closed around the delivery tool and the heartresumes its normal function during the adjustment of the length of theartificial chordea tendinea.

In some applications of the present invention, apparatus and methoddescribed herein may be used for providing artificial chordae tendineaein a left ventricle of the heart and effecting adjustment thereof. Insome applications, apparatus and method described herein may be used forproviding artificial chordae tendineae in a right ventricle of the heartand effecting adjustment thereof. In some applications, apparatus andmethod described herein may be used for providing a system to adjust alength between two portions of the heart wall. For other applicationsapparatus and method described herein may be used for providing adocking station for an annuloplasty ring or for a prosthetic valve.

There is therefore provided, in accordance with an application of thepresent invention, apparatus, including:

a guide member;

a tissue-adjustment mechanism having:

-   -   an upper surface and a lower surface,    -   at least one first opening at the upper surface,    -   at least one second opening at the lower surface, and    -   a channel extending between the first and second openings, the        channel facilitating advancement of the tissue-adjustment        mechanism along the guide member; and

at least one repair chord coupled at a first portion thereof to thetissue-adjustment mechanism and having at least a first end that isconfigured to be coupled to a portion of tissue of a patient, the repairchord being configured to adjust a distance between the portion oftissue and the tissue-adjustment mechanism, in response to adjustment ofthe repair chord by the tissue-adjustment mechanism.

There is further provided, in accordance with an application of thepresent invention, a method, including:

coupling a guide member to a portion of tissue of a patient; and

advancing a tissue-adjustment mechanism toward the portion of tissue by:

-   -   threading a portion of the guide member through at least one        channel extending between a first opening in an upper surface of        the tissue-adjustment mechanism and a second opening in a lower        surface of the tissue-adjustment mechanism; and    -   advancing the tissue-adjustment mechanism along the guide member        and toward the portion of tissue.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with tissue of a heart of asubject, the apparatus including:

at least one docking assembly, having:

-   -   a distal portion including a tissue anchor that is configured to        engage a portion of the tissue,    -   a proximal portion, fixedly coupled to the distal portion, and        including at least one docking station that includes a first        coupling;

at least one guide member, reversibly coupled to the at least onedocking station; and

an annuloplasty ring selected from the group consisting of: a partialannuloplasty ring and a full annuloplasty ring, the selectedannuloplasty ring being:

-   -   shaped to define a second coupling, and    -   slidable along the guide member toward the docking station, and    -   configured to be locked to the docking station by the second        coupling being lockable to the first coupling.

In an application, the second coupling is lockable to the first couplingby being pushed against the first coupling.

In an application, the annuloplasty ring is configured to be locked tothe docking station suturelessly.

In an application, the docking assembly is percutaneously deliverable tothe heart of the subject, and the annuloplasty ring is percutaneouslylockable to the docking station.

In an application:

the at least one docking assembly includes a plurality of dockingassemblies,

the at least one guide member includes a respective plurality of guidemembers, each of the guide members being reversibly coupled to arespective docking station of a respective docking assembly,

the selected annuloplasty ring is shaped to define a respectiveplurality of second couplings, and is slidable along the plurality ofguide members toward the plurality of docking assemblies, and

the each of the second couplings is lockable to a respective firstcoupling of a respective docking assembly.

In an application, the selected annuloplasty ring includes an adjustableannuloplasty ring, including a rotatable structure that is:

bidirectionally rotatable to adjust the selected annuloplasty ring,

shaped to define a channel between an upper surface thereof and a lowersurface thereof, the guide member being disposable in the channel, and

shaped to define the second coupling, and

the selected annuloplasty ring is slidable along the guide member by therotatable structure being slidable along the guide member.

In an application:

the selected annuloplasty ring includes:

-   -   a sleeve, having a longitudinal length from a first end thereof        to a second end thereof, and defining lumen therebetween,    -   a flexible longitudinal member, at least part of which is        disposed in at least part of the lumen, and    -   the rotatable structure, and

the rotatable structure is:

-   -   coupled to a first end portion of the flexible longitudinal        member, and    -   bidirectionally rotatable to adjust the longitudinal length of        the sleeve by adjusting a degree of tension of the flexible        longitudinal member.

In an application, the apparatus further includes a rotatable structurelocking mechanism displaceable with respect to the rotatable structure,so as to release the rotatable structure during rotation of therotatable structure, and lock in place the rotatable structure followingrotation of the rotatable structure.

In an application, the apparatus further includes a release rod:

shaped to define a lumen therethrough, the guide member being disposablewithin the lumen of the release rod, and

configured to unlock the rotatable structure locking mechanism by beingslid over the guide member.

There is further provided, in accordance with an application of thepresent invention, apparatus, including:

a docking assembly:

-   -   having a distal portion including a tissue anchor that is        configured to engage cardiac tissue of a subject,    -   having a proximal portion including at least one docking station        that includes a first coupling;

a guide member reversibly coupled to the at least one docking station;and

an adjustable annuloplasty ring selected from the group consisting of: apartial annuloplasty ring and a full annuloplasty ring, the selectedannuloplasty ring:

-   -   (a) including:        -   a sleeve, having a longitudinal length from a first end            thereof to a second end thereof, and defining lumen            therebetween,        -   a flexible longitudinal member, at least part of which is            disposed in at least part of the lumen, and        -   a rotatable structure:            -   coupled to a first end portion of the flexible                longitudinal member,            -   bidirectionally rotatable to adjust the longitudinal                length of the sleeve by adjusting a degree of tension of                the flexible longitudinal member,            -   shaped to define (1) a channel between an upper surface                thereof and a lower surface thereof, the guide member                being disposable in the channel, and (2) a second                coupling, and    -   (b) being slidable along the guide member toward the docking        assembly, and configured to lock the selected annuloplasty ring        to the docking assembly by the second coupling being lockable to        the first coupling.

In an application, the apparatus further includes a rotatable structurelocking mechanism displaceable with respect to the rotatable structure,so as to release the rotatable structure during rotation of therotatable structure, and lock in place the rotatable structure followingrotation of the rotatable structure.

In an application, the apparatus further includes a release rod:

shaped to define a lumen therethrough, the guide member being disposablewithin the lumen of the release rod, and

configured to unlock the rotatable structure locking mechanism by beingslid over the guide member.

There is further provided, in accordance with an application of thepresent invention, a method for use with tissue of a heart of a subject,the method including:

advancing a docking station assembly to the tissue, the docking stationassembly including (1) a distal portion including a tissue anchor thatis configured to engage a portion of the tissue, and (2) a proximalportion, fixedly coupled to the distal portion, and including at leastone docking station that includes a first coupling;

advancing, along a guide member that is reversibly coupled to thedocking station, an annuloplasty ring selected from the group consistingof: a partial annuloplasty ring and a full annuloplasty ring, theselected annuloplasty ring being shaped to define a second coupling; and

locking the selected annuloplasty ring to the docking station by lockingthe second coupling to the first coupling.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with at least one implant,including:

a tissue-engaging element having (a) a distal portion configured toengage at least a first portion of tissue of a patient, and (b) aproximal portion;

at least one docking station coupled to the proximal portion of thetissue-engaging element, the at least one docking station:

-   -   being configured to receive and be coupled to the at least one        implant, and    -   including a locking mechanism configured to lock the implant to        the docking station; and

at least one guide member reversibly coupled to the at least one dockingstation, the at least one guide member being configured for facilitatingslidable advancement of the at least one implant toward the dockingstation.

In an application, the at least one docking station includes two or moredocking stations, and the at least one guide member includes two or moreguide members, each guide member being reversibly coupled to arespective docking station.

In an application, the implant includes at least one implant selectedfrom the group consisting of: a prosthetic cardiac valve and a supportfor receiving a prosthetic cardiac valve, and the at least one dockingstation is configured to receive and be coupled to the selected implant.

In an application, the implant includes a tissue-adjustment deviceselected from the group consisting of: a partial annuloplasty ring and afull annuloplasty ring, and the at least one docking station isconfigured to receive and be coupled to the selected tissue-adjustmentdevice.

In an application, the apparatus further includes the implant.

In an application, the implant has:

-   -   an upper surface and a lower surface,    -   at least one first opening at the upper surface,    -   at least one second opening at the lower surface, and    -   a channel extending between the first and second openings, the        channel facilitating advancement of the implant along the guide        member.

In an application, the implant includes a first coupling, and thelocking mechanism includes a second coupling configured to be coupled tothe first coupling.

In an application, the second coupling includes at least one depressedportion, and the first coupling includes at least one moveable bafflewhich is configured to engage the at least one depressed portion of thesecond coupling.

In an application, the apparatus further includes at least one flexiblelongitudinal member coupled at a first portion thereof to the implant, asecond portion of the flexible longitudinal member is configured to becoupled to a second portion of tissue of the patient, and the implant isconfigured to adjust a length of the longitudinal member between thefirst and second portions of tissue.

In an application:

the first portion of tissue includes a first portion of cardiac tissueat a first intraventricular site,

the second portion of tissue includes at least one leaflet of anatrioventricular valve of the patient, and

the flexible longitudinal member includes at least one artificialchordea tendinea.

In an application:

the implant includes a rotatable structure,

the at least one flexible longitudinal member is coupled at the firstportion to the rotatable structure, and

the rotatable structure is bidirectionally rotatable to adjust thedegree of tension of the at least one flexible longitudinal member.

In an application, the rotatable structure is configured such that:

rotation of the rotatable structure in a first rotational directionapplies tension to the flexible longitudinal member, and

rotation of the rotatable structure in a second rotational directionthat is opposite the first rotational direction slackens the flexiblelongitudinal member.

In an application, the apparatus further includes a rotatable structurelocking mechanism displaceable with respect to the rotatable structure,so as to:

release the rotatable structure during rotation of the rotatablestructure, and lock in place the rotatable structure following rotationof the rotatable structure.

In an application, the rotatable structure includes a spool, and the atleast one flexible longitudinal member is configured to be wound aroundthe spool during the rotation of the spool in a first rotationaldirection.

In an application:

the implant includes a rotatable structure, coupled to a flexiblelongitudinal member,

the rotatable structure is bidirectionally rotatable to adjust a degreeof tension of the flexible longitudinal member, and

the at least one docking station is configured to receive and be coupledto the rotatable structure.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with at least one implant,including:

a tissue-engaging element having (a) a distal portion configured toengage at least a first portion of tissue of a patient, and (b) aproximal portion;

at least one docking station coupled to the proximal portion of thetissue-engaging element, the at least one docking station:

-   -   being configured to receive and be coupled to the at least one        implant, and    -   including a locking mechanism configured to lock the implant to        the tissue-engaging element; and

at least one guide member reversibly coupled to the at least one dockingstation, the at least one guide member being configured for facilitatingslidable advancement of the at least one implant toward thetissue-engaging element.

In an application, the guide member is looped around a portion of thedocking station.

In an application, the at least one docking station includes two or moredocking stations, and the at least one guide member includes two or moreguide members, each guide member being reversibly coupled to arespective docking station.

In an application, the implant includes a prosthetic cardiac valve.

In an application, the implant includes a support for receiving aprosthetic cardiac valve.

In an application, the implant includes a tissue-adjustment device.

In an application, the tissue-adjustment device includes an annuloplastyring structure selected from the group consisting of: a partialannuloplasty ring and a full annuloplasty ring.

In an application, the apparatus further includes the implant, and theimplant has:

-   -   an upper surface and a lower surface,    -   at least one first opening at the upper surface,    -   at least one second opening at the lower surface, and    -   a channel extending between the first and second opening, the        channel facilitating advancement of the implant along the guide        member.

In an application, the implant includes a prosthetic cardiac valve.

In an application, the implant includes a support for receiving aprosthetic cardiac valve.

In an application, the implant includes a tissue-adjustment device.

In an application, the tissue-adjustment device includes an annuloplastyring structure selected from the group consisting of: a partialannuloplasty ring and a full annuloplasty ring.

In an application, the implant includes a first coupling, and thelocking mechanism includes a second coupling configured to be coupled tothe first coupling.

In an application, the second coupling includes at least one depressedportion, and the first coupling includes at least one moveable bafflewhich is configured to engage the at least one depressed portion of thesecond coupling.

In an application, the apparatus further includes at least one flexiblelongitudinal member coupled at a first portion thereof to the implant, asecond portion of the flexible longitudinal member is configured to becoupled to a second portion of tissue of the patient, and the implant isconfigured to adjust a length of the longitudinal member between thefirst and second portions of tissue.

In an application:

the first portion of tissue includes a first portion of cardiac tissueat a first intraventricular site,

the second portion of tissue includes at least one leaflet of anatrioventricular valve of the patient, and

the flexible longitudinal member includes at least one artificialchordea tendinea.

In an application:

the implant includes a rotatable structure,

the at least one flexible longitudinal member is coupled at the firstportion to the rotatable structure, and

the rotatable structure is bidirectionally rotatable to adjust thedegree of tension of the at least one flexible longitudinal member.

In an application, during rotation of the rotatable structure in a firstrotational direction, successive portions of the flexible longitudinalmember advance in a first advancement direction with respect to therotatable structure and contact the rotatable structure, to pull thesecond portion of the flexible member toward the rotatable structure,and to draw the first and second portions of tissue toward each other.

In an application, the apparatus further includes a rotatable structurelocking mechanism displaceable with respect to the rotatable structure,so as to:

release the rotatable structure during rotation of the rotatablestructure, and

lock in place the rotatable structure following rotation of therotatable structure.

In an application, the rotatable structure includes a spool, and the atleast one flexible longitudinal member is configured to be wound aroundthe spool during the rotation of the spool in a first rotationaldirection.

In an application, the first portion of the at least one flexiblelongitudinal member is looped through a portion of the spool.

In an application, the first portion of the at least one flexiblelongitudinal member is wound around a portion of the spool, and thefirst portion of the at least one flexible longitudinal member isconfigured to be unwound from around the portion of the spool followingthe coupling of the second portion of the flexible longitudinal memberto the second portion of tissue of the patient.

There is further provided, in accordance with an application of thepresent invention, apparatus, including:

a tissue-engaging element having a distal portion configured to engageat least a first portion of tissue of a patient, and having a proximalportion;

at least one docking station coupled to the proximal portion of thetissue-engaging element, the at least one docking station beingconfigured to be coupled to the at least one tissue-adjustment device;

a implant including:

-   -   a rotatable structure; and    -   at least one flexible longitudinal member having a first portion        thereof that is in contact with the rotatable structure, and a        second portion thereof that is configured to be coupled to a        second portion of tissue of the patient,    -   and during rotation of the rotatable structure in a first        rotational direction, successive portions of the flexible        longitudinal member advance in a first advancement direction        with respect to the rotatable structure and contact the        rotatable structure, and, pull the second portion of the        flexible longitudinal member toward the implant, and        responsively, to draw the first and second portions of tissue        toward each other; and

at least one guide member reversibly coupled to the at least one dockingstation, the at least one guide member being configured for facilitatingslidable advancement of the at least one implant toward thetissue-engaging element.

In an application, the guide member is looped around a portion of thedocking station.

In an application, the at least one docking station includes two or moredocking stations, and the at least one guide member includes two or moreguide members, each guide member being reversibly coupled to arespective docking station.

In an application, the implant includes a support for receiving aprosthetic cardiac valve.

In an application, the implant includes a tissue-adjustment device.

In an application, the tissue-adjustment device includes an annuloplastyring structure selected from the group consisting of: a partialannuloplasty ring and a full annuloplasty ring.

In an application, the implant has:

-   -   an upper surface and a lower surface,    -   at least one first opening at the upper surface,    -   at least one second opening at the lower surface, and    -   a channel extending between the first and second opening, the        channel facilitating advancement of the implant along the guide        member.

In an application, the implant includes a first coupling, and thedocking station includes a second coupling configured to be coupled tothe first coupling.

In an application, the second coupling includes at least one depressedportion, and the first coupling includes at least one moveable bafflewhich is configured to engage the at least one depressed portion of thesecond coupling.

In an application, the second coupling includes a locking mechanismconfigured to lock the implant to the tissue-engaging element.

In an application:

the first portion of tissue includes a first portion of cardiac tissueat a first intraventricular site,

the second portion of tissue includes at least one leaflet of anatrioventricular valve of the patient, and

the flexible longitudinal member includes at least one artificialchordea tendinea.

In an application, the rotatable structure is rotatable in a firstrotational direction to apply tension to the flexible longitudinalmember, and in a second rotational direction that is opposite the firstrotational direction to slacken the flexible longitudinal member.

In an application, during rotation of the rotatable structure in a firstrotational direction thereof, successive portions of the flexiblelongitudinal member advance in a first advancement direction withrespect to the rotatable structure and contact the rotatable structure,responsively, to pull the second portion of the flexible longitudinalmember toward the rotatable structure.

In an application, the apparatus further includes a rotatable structurelocking mechanism, displaceable with respect to the rotatable structureso as to:

release the rotatable structure during rotation of the rotatablestructure, and

lock in place the rotatable structure following rotation of therotatable structure.

In an application, the rotatable structure includes a spool, and the atleast one flexible longitudinal member is configured to be wound aroundthe spool during the rotation of the spool in the first rotationaldirection.

In an application, the first portion of the flexible longitudinal memberis looped through a portion of the spool.

In an application, the first portion of the flexible longitudinal memberis wound around a portion of the spool, and the first portion of theflexible longitudinal member is configured to be unwound from around theportion of the spool following the coupling of the second portion of theflexible longitudinal member to the second portion of tissue of thepatient.

There is further provided, in accordance with an application of thepresent invention, apparatus, including:

a guide member;

a tissue-adjustment mechanism having:

-   -   an upper surface and a lower surface,    -   at least one first opening at the upper surface,    -   at least one second opening at the lower surface, and    -   a channel extending between the first and second openings, the        channel facilitating advancement of the tissue-adjustment        mechanism along the guide member; and

at least one repair chord coupled at a first portion thereof to thetissue-adjustment mechanism and having at least a first end that isconfigured to be coupled to a portion of tissue of a patient, the repairchord being configured to adjust a distance between the portion oftissue and the tissue-adjustment mechanism, in response to adjustment ofthe repair chord by the tissue-adjustment mechanism.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-2 are schematic illustrations of apparatus comprising atissue-engaging element comprising a docking station coupled to a guidewire, in accordance with some applications of the present invention;

FIG. 3 is a schematic illustration of advancement of an adjustmentmechanism along the guide wire toward the docking station of FIGS. 1 and2, in accordance with some applications of the present invention;

FIGS. 4-5 are schematic illustrations of engaging a leaflet with aleaflet engaging element, in accordance with some applications of thepresent invention;

FIG. 6 is a schematic illustration of coupling of the adjustmentmechanism of FIG. 3 to the docking station, in accordance with someapplications of the present invention;

FIGS. 7-9 are schematic illustrations of adjusting by the adjustmentmechanism a length of a repair chord coupled to the adjustmentmechanism, in accordance with some applications of the presentinvention;

FIG. 10 is a schematic illustration of the adjustment mechanism and therepair chord, in accordance with some other applications of the presentinvention;

FIGS. 11-15 are schematic illustrations of a plurality of dockingstations and a plurality of adjustment mechanisms, in accordance withsome applications of the present invention;

FIG. 16 is a schematic illustration of wall-to-wall adjustment using thedocking station, adjustment mechanism, and repair chord, in accordancewith some applications of the present invention;

FIG. 17 is a schematic illustration of wall-to-wall adjustment andleaflet adjustment using the plurality of docking stations, theplurality of adjustment mechanisms, and the plurality of repair chords,in accordance with some applications of the present invention;

FIG. 18 is a schematic illustration of wall-to-wall adjustment using thedocking station, adjustment mechanism, and repair chord, in accordancewith some other applications of the present invention;

FIGS. 19-20 are schematic illustrations of adjustment of a valve of apatient from a middle portion of the valve, in accordance with someapplications of the present invention;

FIG. 21 is a schematic illustration of the tissue-engaging element andthe docking station of FIGS. 1 and 2 being used to facilitateimplantation of an implant at a cardiac valve, in accordance with someapplications of the present invention; and

FIG. 22 is a schematic illustration of the tissue-engaging element andthe docking station of FIGS. 1 and 2 being used to facilitateimplantation of an annuloplasty ring at a cardiac valve, in accordancewith some applications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to FIGS. 1-2, which are schematic illustrations ofa system 20 comprising a docking assembly 150 for implantation at afirst implantation site 5 of a patient, in accordance with someapplications of the present invention. As shown in FIG. 2, dockingassembly 150 comprises a tissue-engaging element having (1) a distalportion comprising a tissue anchor 50 (e.g., a helical tissue anchor asshown by way of illustration and not limitation), and (2) a proximalportion comprising a docking platform 54, and at least one dockingstation 56. Thus, docking assembly 150 comprises (a) the distal portionwhich engages the tissue of the patient (i.e., the tissue-engagingelement), and (b) the proximal portion which is coupled to dockingstation 56. It is to be noted that the distal portion and the proximalportion are fixedly coupled to each other (e.g., immovable with respectto each other), and thereby docking station 56 and tissue anchor 50 arefixedly coupled to each other (e.g., immovable with respect to eachother). Docking assembly 150 is thereby an integrated unit thatcomprises the docking station and tissue anchor. At least one guidemember, (e.g., a guide wire 40, shown in FIG. 2) is reversibly coupledto docking assembly 150 (e.g., by being looped around, or otherwisecoupled to, a portion of assembly 150) so as to define first and secondportions 40 a and 40 a′ that extend away from assembly 150.

Tissue anchor 50 is typically implanted within cardiac tissue in amanner in which a distal portion of anchor 50 does not extend beyond anepicardium of heart 2 of the patient. Thus, anchor 50 is implanted at anintracardiac site such that the implant, (e.g., the adjustment mechanismor an implant comprising the adjustment mechanism) that is eventuallycoupled thereto (as described hereinbelow) is implanted at theintracardiac site such that no portions of the adjustment mechanismextend beyond the epicardium of the heart.

Docking assembly 150 and guide wire 40 are advanced toward implantationsite typically during a transcatheter procedure, as shown. However, itis to be noted that the scope of the present invention includes theadvancement of assembly 150 and guide wire 40 during aminimally-invasive or open-heart procedure. The procedure is typicallyperformed with the aid of imaging, such as fluoroscopy, transesophagealecho, and/or echocardiography.

The transcatheter procedure typically begins with the advancing of asemi-rigid guide wire into a right atrium of the patient. The semi-rigidguide wire provides a guide for the subsequent advancement of a sheath28 therealong and into the right atrium. Once sheath 28 has entered theright atrium, the semi-rigid guide wire is retracted from the patient'sbody. Sheath 28 typically comprises a 13-20 F sheath, although the sizemay be selected as appropriate for a given patient. Sheath 28 isadvanced through vasculature into the right atrium using a suitablepoint of origin typically determined for a given patient. For example:

sheath 28 may be introduced into the femoral vein of the patient,through an inferior vena cava, into the right atrium, and into the leftatrium transseptally, typically through the fossa ovalis;

sheath 28 may be introduced into the basilic vein, through thesubclavian vein to the superior vena cava, into the right atrium, andinto the left atrium transseptally, typically through the fossa ovalis;or

sheath 28 may be introduced into the external jugular vein, through thesubclavian vein to the superior vena cava, into the right atrium, andinto the left atrium transseptally, typically through the fossa ovalis.

In some applications of the present invention, sheath 28 is advancedthrough the inferior vena cava of the patient (as shown) and into theright atrium using a suitable point of origin typically determined for agiven patient.

Sheath 28 is advanced distally until the sheath reaches the interatrialseptum. For some applications, a resilient needle and a dilator (notshown) are advanced through sheath 28 and into the heart. In order toadvance sheath 28 transseptally into the left atrium, the dilator isadvanced to the septum, and the needle is pushed from within the dilatorand is allowed to puncture the septum to create an opening thatfacilitates passage of the dilator and subsequently sheath 28therethrough and into the left atrium. The dilator is passed through thehole in the septum created by the needle. Typically, the dilator isshaped to define a hollow shaft for passage along the needle, and thehollow shaft is shaped to define a tapered distal end. This tapereddistal end is first advanced through the hole created by the needle. Thehole is enlarged when the gradually increasing diameter of the distalend of the dilator is pushed through the hole in the septum.

The advancement of sheath 28 through the septum and into the left atriumis followed by the extraction of the dilator and the needle from withinsheath 28. Subsequently, a docking-assembly delivery tool 30 is advancedthrough sheath 28. Tool 30 is typically advanced within a lumen of anadvancement sheath 22 having a distal end 24. Advancement sheath 22 isadvanced within sheath 28. Delivery tool 30 is coupled at a distal endthereof to a manipulator 32 which is reversibly coupled to dockingstation 56 and docking platform 54 of docking assembly 150. Manipulator32 has (1) lateral arms which cup platform 54, and (2) adocking-station-coupler 34, as shown in FIG. 1. Coupler 34 is biased tomove radially-inward, as shown in FIG. 1. Docking station 56 is ribbed,such that coupler 34, when moved radially inward, engages at least onerib of docking station 56, thereby coupling assembly 150 to deliverytool 30.

Delivery tool 30 and manipulator 32 are shaped so as to define a lumenfor passage therethrough of guide wire 40.

Docking assembly 150 is implanted in implantation site 5 by rotatingtool 30 in order to rotate anchor 50 and corkscrew anchor 50 into tissueof site 5. Site 5 typically comprises a portion of tissue at anintraventricular site in heart 2 of the patient. As shown, site 5includes a papillary muscle 4, by way of illustration and notlimitation. It is to be noted that site 5 includes any portion ofcardiac tissue, e.g., a portion of a free wall of the ventricle, aportion of the septum facing the ventricle, a portion of tissue at abase of the papillary muscle, or a portion of the wall at the apex ofthe ventricle. (For the purposes of the claims, “a portion of tissue ofa ventricle” includes any portion of cardiac tissue, e.g., a portion ofa free wall of the ventricle, a portion of the septum facing theventricle, a portion of tissue at a base of the papillary muscle, or aportion of the wall at the apex of the ventricle.)

Following the implantation of assembly 150 at site 5, tool 30 isdisengaged from assembly 150 when the physician pulls on tool 30. Thispulling pulls on manipulator 32 such that coupler 34 is actively movedradially outward against the ribs of docking station 56, and is therebydecoupled from station 56. At the time of pulling, tissue atimplantation site 5 pulls on assembly 150 (in the direction opposite thedirection of pulling by the physician) so as to help disengage tool 30from assembly 150.

As shown in FIG. 2, following the decoupling of tool 30 from assembly150, tool 30 is pulled proximally along guide wire 40 and is extractedfrom the body of the patient together with advancement sheath 22,leaving behind assembly 150 and guide wire 40.

FIG. 3 shows advancement of an implant (e.g., a spool assembly 36comprising an adjustment mechanism 43) along guide wire 40 by anadjustment-mechanism delivery tool 64, in accordance with someapplications of the present invention. Tool 64 is surrounded by andslidable within an advancement sheath 60 having a distal end 62.

Spool assembly 36 is surrounded by a braided fabric mesh, e.g., apolyester mesh, which promotes fibrosis around assembly 36 andfacilitates coupling of assembly 36 to tissue of heart 2. Assembly 36houses a rotatable structure (e.g., a spool as shown hereinbelow) thatis surrounded by a housing 49. Housing 49 is coupled to a distal cap 44which facilitates coupling of assembly 36 to docking station 56 ofdocking assembly 150. As shown, cap 44 is shaped so as to define aplurality of baffles 47 that are disposed angularly with respect to adistal end of cap 44. Baffles 47 are coupled to the distal end of cap 44along respective coupling joints which facilitate movement of eachbaffle 47. During the coupling of spool assembly 36 to docking station56, the ribbed portion of docking station 56 pushes inwardly baffles 47of cap 44, as is described hereinbelow. Baffles 47 then expand andengage an area of docking station 56 between the ribs of the ribbedportion so as to dock and lock assembly 36 to docking station 56.

Additionally, cap 44 is shaped so as to define a central openingtherethrough which facilitates passage therethrough of guide wire 40.Additionally, spool assembly 36 and the components thereof are shaped soas to define a central opening (i.e., an opening having the same axis asguide wire 40). That is, spool 46 has a central opening, and housing 49has a central opening which facilitates passage of spool 46 and housing49 along guide wire 40.

As shown, adjustment mechanism 43 is coupled to a distal portion of arepair chord 74 (e.g., repair chord 74 is looped through or otherwisecoupled to a portion of adjustment mechanism 43). Chord 74 comprises aflexible longitudinal member. For some applications, and as is describedhereinbelow, chord 74 functions as an artificial chordea tendinea. Aproximal portion of chord 74 is coupled to a leaflet-engaging element 72(e.g., a clip, as shown). Leaflet-engaging element 72 is disposed withina holder 70 that is coupled to delivery tool 64. Chord 74 asuperelastic, biocompatible material (e.g., nitinol, ePTFE, PTFE,polyester, stainless steel, or cobalt chrome). Typically, chord 74comprises an artificial chordea tendinea.

FIGS. 4-5 are schematic illustrations of the engaging ofleaflet-engaging element 72 to at least one leaflet 14 of a mitral valveof the patient, in accordance with some applications of the presentinvention. As shown in FIG. 4, the clip is opened from a remote locationoutside the body of the patient.

For some applications, the clip typically is shaped so as to define atleast one coupling protrusion 73. The clip has a tendency to close, andis initially held open by a cord (not shown) that is coupled to asurface of the clip, extends through delivery tool 64, and is heldtaught outside of the heart. Once the clip has been advanced to thedesired location on the leaflet, the cord is relaxed, allowing the clipto close. The cord is removed, typically by releasing one end thereofand pulling the other end. The positioning of holder 70 between theleaflets (FIG. 5) helps ensure that the clip engages exactly one of theleaflets. It is noted that in FIG. 5 the clip is shown engaging only asingle leaflet (leaflet 14). The clip typically engages the leaflet byclamping the leaflet such that the clip engages atrial and ventricularsurfaces of the leaflet. The clip may puncture the leaflet, or maymerely press firmly against the leaflet.

It is to be noted that the scope of the present invention include theclipping together of both leaflets 12 and 14. For applications in whichsystem 20 is used to repair a tricuspid valve of the patient, the clipmay clip any one, two, or all three leaflets together.

Holder 70 is shaped to define a groove which houses the clip during theadvancement of tool 64 toward the ventricle. The groove functions as atrack to facilitate slidable detachment of the clip from holder 70following the engaging of the clip to leaflet 14.

Alternatively, the clip has a tendency to open. In order to close theclip, a cord is provided. A distal-most portion of the cord is loopedaround the clip. Once the clip has been advanced to the desired locationon the leaflet, as shown in FIG. 5, the surgeon pulls on both ends ofthe cord, thereby causing the clip to become locked closed. The cord isremoved, typically by releasing one end thereof and pulling the otherend.

It is to be noted that the scope of the present invention includes anyleaflet-engaging element known in the art.

As shown in FIG. 5, portions 74 a and 74 b extend from leaflet-engagingelement 72 toward adjustment mechanism 43. Portions 74 a and 74 b defineportions of a single chord 74 that is looped through a portion ofmechanism 43. Alternatively, portions 74 a and 74 b represent twodistinct chords which are coupled at their distal ends to adjustmentmechanism 43 and at their proximal ends to leaflet-engaging element 72.

As shown, leaflet-engaging element 72 engages leaflet 14 prior tocoupling spool assembly 36 to docking station 56.

FIG. 6 shows spool assembly 36 being coupled to docking station 56, inaccordance with some applications of the present invention. Followingthe coupling of leaflet-engaging element 72 to leaflet 14, spoolassembly 36 is pushed distally toward docking station 56. Spool assembly36 is coupled to an advancement shaft 80 which pushes assembly 36. Shaft80 slides within a lumen of delivery tool 64 and within a lumen ofholder 70 so as to advance spool assembly 36, while leaflet-engagingelement 72 remains engaged with leaflet 14. Advancement shaft 80functions to advance distally spool assembly 36 and functions tofacilitate engagement between spool assembly 36 and docking station 56.

As described hereinabove, docking station 56 has one or more lockingmechanisms (e.g., one or more ribs 57, shown in the enlargedcross-sectional image of FIG. 6) which project laterally such that rib57 defines a shelf and an depressed area underneath the shelf (i.e., thecross-sectional diameter at rib 57 is larger than the cross-sectionaldiameter at the area underneath the shelf). As described hereinabove,cap 44 of assembly 36 is shaped so as to define a plurality of baffles47. As cap 44 engages docking station 56, baffles 47 are pushed inwardand upward angularly as each baffle slides against rib 57. After eachbaffle 47 passes the shelf of rib 57, the baffle engages the depressedarea underneath the shelf of rib 57, as shown in the enlargedcross-sectional image of FIG. 6. The shelf of rib 57 prevents upwardmovement of baffles 47 and thereby locks in place baffles 47 and cap 44with respect to docking station 56. Rib 57, therefore, comprises alocking mechanism so as to lock implant 42 (e.g., adjustment mechanism43) to tissue anchor 50.

Following the coupling of assembly 36 to docking station 56, spool 46 isrotated in a first rotational direction in order to advance with respectto spool 46 and contact with spool 46 successive portions of chord 74.For example, when the successive portions of chord 74 are advanced withrespect to spool 46, the successive portions of chord 74 are loopedaround spool 46. The rotating of spool 46 in the first rotationaldirection pulls tight and adjusts a length of chord 74 between leaflet14 and spool 46, in order to adjust a distance between leaflet 14 andimplantation site 5 and to facilitate coaptation between leaflets 12 and14, as is described hereinbelow.

Housing 49 is shaped so as to provide openings 41 a and 41 b for passagetherethrough of portions 74 a and 74 b, respectively, of chord 74 intohousing 49. For some applications of the present invention, portions 74a and 74 b define portions of a single chord 74 that is looped throughspool 46. For other applications, portions 74 a and 74 b define discretechords which are each coupled at respective distal ends thereof to spool46.

The enlarged, cross-sectional image of FIG. 6 shows spool 46 withinhousing 49. Spool 46 defines an upper surface 150, a lower surface 152,and a cylindrical body portion disposed vertically between surfaces 150and 152. Spool 46 is shaped to provide a driving interface, e.g., achannel, which extends from an opening provided by upper surface 150 toan opening provided by lower surface 152. A proximal portion of thedriving interface is shaped to define a threaded portion 146 which mayor may not be tapered. Threaded portion 146 of spool 46 is engageable bya threaded portion of a screwdriver head 92 of a screwdriver 90.Screwdriver 90 is coupled to a distal end of shaft 80. For someapplications, shaft 80 rotates screwdriver 90. For other applications,shaft 80 is shaped so as to define a lumen for advancement therethroughof a screwdriver-rotation tool that facilitates rotation of screwdriver90. Rotation of screwdriver 90 and screwdriver head 92 rotates spool 46,as the respective threaded portions of spool 46 and screwdriver head 92engage. The cylindrical body portion of spool 46 is shaped to define oneor more holes which function as respective coupling sites for coupling(e.g., looping through the one or more holes, or welding to spool 46 inthe vicinity of the one or more holes) of any number of chords 74 tospool 46.

Lower surface 152 of spool 46 is shaped to define one or more (e.g., aplurality, as shown) recesses 154 which define structural barrierportions 155 of lower surface 152. It is to be noted that any suitablenumber of recesses 154 may be provided, e.g., between 1 and 10 recesses,circumferentially or otherwise, with respect to lower surface 152 ofspool 46.

As shown, a locking mechanism 45 is disposed in communication with lowersurface 152 of spool 46 and disposed in communication with at least inpart to a lower surface of housing 49. Typically, a cap 44 maintainslocking mechanism 45 in place with respect to lower surface 152 of spool46 and lower surface of housing 49. For some applications, lockingmechanism 45 is coupled, e.g., welded, to the lower surface of housing49. Typically, locking mechanism 45 defines a mechanical element havinga planar surface that defines slits. It is to be noted that the surfaceof locking mechanism 45 may also be curved, and not planar. Lockingmechanism 45 is shaped to provide a protrusion 156 which projects out ofa plane defined by the planar surface of the mechanical element. Theslits of mechanism 45 define a depressible portion 128 that is disposedin communication with and extends toward protrusion 156. Depressibleportion 128 is moveable in response to a force applied thereto typicallyby an elongate locking mechanism release rod 94 which slides through alumen of screwdriver 90 and a torque-delivering tool that is coupledthereto.

It is to be noted that the planar, mechanical element of lockingmechanism 45 is shown by way of illustration and not limitation and thatany suitable mechanical element having or lacking a planar surface butshaped to define at least one protrusion may be used together withlocking mechanism 45.

Cap 44 is provided that is shaped to define a planar surface and anannular wall having an upper surface thereof. The upper surface of theannular wall is coupled to, e.g., welded to, a lower surface provided byhousing 49. The annular wall of cap 44 is shaped to define a recessedportion 144 of cap 44 that is in alignment with a recessed portion 142of spool housing 49.

As shown, a distal end 96 of locking mechanism release rod 94 pushesdistally on depressible portion 128 in order to unlock locking mechanism45 from spool 46. Pushing depressible portion 128 by locking mechanismrelease rod 94 pushes distally protrusion 156 within recessed portion142 of housing 49 and within recessed portion 144 of cap 44, which freesprotrusion 156 from recesses 154 of spool 46. Once protrusion 156 isreleased from recesses 154 of spool 46, the physician is able to rotatespool 46 bidirectionally in order to adjust a tension of chord 74.

When the physician rotates spool 46 in the first rotational direction,chord 74 is pulled tight, and leaflet 14 is drawn toward adjustmentmechanism 40 and toward anterior leaflet 12 of mitral valve 8.

In the resting state (i.e., prior to the rotation of spool 46 in orderto adjust chord 74, following coupling of leaflet-engaging element 72 toleaflet 14) chord 74 is wrapped around spool 46 a few times (e.g., threetimes, by way of illustration and not limitation). This winding providesexcess slack to chord 74 (in case portions 74 a and 74 b are coupled tootightly to leaflet 14). If the physician wishes to provide slack tomember 74 or to any one of portion 74 a or 74 b, the physician unwinds abit of the wrapped portion of member 74 from around spool 46 (e.g., byunwinding chord 74 a few times from around spool 46, or by unwindingchord 74 entirely from around spool 46 so that chord 74 slides freelythrough spool 46 within a channel provided therein). In order toaccomplish such unwinding, the physician rotates spool 46 in arotational direction in which it unwinds the wrapped portion of chord74. Since chord 74 is looped through spool 46 in the channel providedtherein, when chord 74 is unwound from spool 46, the physician can pullon one or both portions 74 a and 74 b so as to adjust, make even, orfurther slacken any one of or both portions 74 a and 74 b that extendfrom spool 46.

When the physician desires to pull tight chord 74, he or she effectsrotation of spool 46 in a first rotational direction, i.e., thedirection opposite the second rotational direction in which spool 46 isrotated during the unwinding of chord 74 from spool 46. Rotation ofspool 46 in the first rotational direction winds chord 74 around spool46, while rotation of spool 46 in a second rotational direction that isopposite the first rotational direction, unwinds the portion oflongitudinal chord 74 from around spool 46.

FIG. 7 shows spool assembly 36 following the adjustment of chord 74 byrotating screwdriver 90 in the direction as indicated by the arrow, andthe partial removal of screwdriver 90, in accordance with someapplications of the present invention. As shown in the enlargedcross-sectional image of FIG. 7, successive portions of chord 74 arewrapped around spool 46. That is, chord 74 is wrapped more times aroundspool 46 following adjustment (e.g., an additional 4 times, as shown inFIG. 7), than prior to adjustment (FIG. 6). This pulls chord 74 from aslackened state (FIG. 6) to a taut state (FIG. 7) in order to adjust alength of chord 74 between adjustment mechanism 43 and the proximal endof chord 74 that is coupled to leaflet-engaging element 72.Additionally, this applying of tension to chord 74 adjusts a lengthbetween first and second implantation sites 5 and 7. Typically, chord 74is adjusted while heart 2 is beating.

As shown, rod 94 is shaped so as to define a central lumen and a distalopening for passage therethrough of guide wire 40. Additionally,depressible portion 128 is shaped so as to provide an opening forpassage of guide wire 40 therethrough. Guide wire 40 is looped around adistal looping element 55 of docking platform 54 of docking assembly150. Following the adjusting of the tension and length of chord 74,screwdriver 90 is decoupled from spool 46 (e.g., by being unscrewed fromthreaded portion 146 of spool 46) and is advanced proximally togetherwith rod 94 away from spool assembly 36, as shown in the enlarged,cross-sectional image of FIG. 7.

Following the decoupling of screwdriver 90 from spool 46 and the removalof screwdriver 90, guide wire 40 remains coupled to docking platform 54and docking assembly 150. Guide wire 40 then facilitates subsequentadvancement of screwdriver 90 or any other tool to access spool assembly36 and/or to facilitate further adjustment of chord 74 beyond theinitial adjustment. Guide wire 40 may remain chronically coupled todocking assembly 150 and may be accessible at a subcutaneous location ofthe patient, e.g., a port. For other applications, guide wire 40 isremoved from docking assembly 150 when the physician determines thatfurther adjustment of chord 74 is not needed. The physician removesguide wire 40 by pulling, from outside the body of the patient, one endof guide wire 40 so that guide wire 40 slides around element 55 and isunlooped therefrom. The physician continues to pull on the end of guidewire 40 until the second end of wire 40 is exposed and removed from thepatient.

Following the removal of locking-mechanism release rod 94, depressibleportion 128 is no longer depressed by distal end 96 of rod 94, andprotrusion 156 returns within a recess 154 of spool 46 so as to lockspool 46 in place and restriction rotation thereof in either direction(FIG. 7).

Reference is now made to FIGS. 3-7. It is to be noted that spoolassembly 36 is only coupled to docking assembly 150 following thecoupling of leaflet-engaging element 72 to leaflet 14. This is done inorder to reduce the strain on implantation site 5. Should spool assembly36 be implanted at implantation site 5 prior to engaging leaflet 14 withleaflet-engaging element 72, more strain would be applied toimplantation site 5 than if spool assembly 36 had been implantedfollowing the coupling of leaflet-engaging element 72 to leaflet 14, asdescribed herein. That is, the pulling force is applied in a downwarddirection from leaflet 14 toward implantation site 5 instead of fromimplantation site 5 upward toward leaflet 14.

FIG. 8 shows system 20 following the removal of the tool used to rotatespool 46 of spool assembly 36, in accordance with some applications ofthe present invention. As shown, chord 74 is pulled tight such that itslength and tension are adjusted, and leaflet 14 is pulled and adjustedcommensurate with the adjustment of chord 74. Guide wire 40 remainscoupled to spool assembly 36 and to docking assembly 150, as shown, suchthat portions 40 a and 40 a′ extend from spool assembly 36. Guide wire40 facilitates the reintroduction of the tool used to rotate spool 46,or of any other tool.

FIG. 9 shows system 20 following the removal of guide wire 40 from heart2, in accordance with some applications of the present invention. Asshown, the adjustment of chord 74 draws leaflets 12 and 14 together. Itis to be noted that although leaflet-engaging element 72 is shown asengaging only leaflet 14, the scope of the present invention includesthe engaging of both leaflets 12 and 14 by leaflet-engaging element 72.

FIG. 10 shows a system 220, as described hereinabove with reference tosystem 20, with the exception that implantation site 5 includes tissueof the wall of the ventricle at the base of papillary muscle 4 in avicinity of the apex of the heart, in accordance with some applicationsof the present invention. Implantation site 5 is shown by way ofillustration and not limitation, and as described hereinabove, site 5may include any portion of tissue of heart 2. It is to be noted thatalthough leaflet-engaging element 72 is shown as engaging only leaflet14, the scope of the present invention includes the engaging of bothleaflets 12 and 14 by leaflet-engaging element 72.

FIGS. 11-15 are schematic illustrations of a system 320 comprising amultiple-docking-station assembly 350 comprising a plurality of dockingstations 56, in accordance with some applications of the presentinvention. Multiple-docking-station assembly 350 comprises a tissueanchor 50 and a docking platform 322 which supports two or more dockingstations 56. Platform 322, as shown, supports three docking stations 56a, 56 b, and 56 c, by way of illustration and not limitation. It is tobe noted that platform 322 may support any number of docking stations56. As shown, each docking station 56 a, 56 b, and 56 c is reversiblycoupled to a respective guide wire 40 a, 40 b, and 40 c, in a manner asdescribed hereinabove. Each docking station 56 a, 56 b, and 56 cfacilitates coupling thereto of a respective spool assembly 36 a, 36 b,and 36 c, or any other tool or device which may be coupled to dockingstations 56 a, 56 b, and 56 c.

As shown in FIGS. 11-13, first and second spool assemblies 36 a and 36 bare coupled via respective guide wires 40 a and 40 b to respectivedocking stations 56 a and 56 b. Each spool assembly 36 a and 36 b has arespective chord 74 aa and 74 bb extending therefrom (FIG. 13). Forexample (as shown in FIG. 12), the chord extending from spool assembly36 a has portions 74 aa and 74 aa′ extending from spool assembly 36 a.Each chord 74 is coupled to a respective leaflet-engaging element 72.That is, chord 74 aa is coupled to leaflet-engaging element 72 a, andchord 74 bb is coupled to leaflet-engaging element 72 b (FIG. 13).

Each leaflet-engaging element 72 a and 72 b is coupled to leaflets 12and 14, respectively, and then each spool assembly 36 a and 36 b iscoupled to respective docking stations 56 a and 56 b, in a manner asdescribed hereinabove. Chords 74 aa and 74 bb are then adjusted, asdescribed hereinabove. Each chord 74 aa and 74 bb may be adjustedsequentially or simultaneously.

FIG. 13 shows chords 74 aa and 74 bb following their adjustment. Therelative dispositions of leaflets 12 and 14 are adjusted in conjunctionwith the adjusting of chords 74 aa and 74 bb. Typically, leaflets 12 and14 are drawn together to repair the heart valve.

As shown in FIG. 15, a third spool assembly 36 c may be coupled todocking station 56 c. Chord 74 c coupled thereto may be coupled to athird implantation site in heart 2 and subsequently adjusted. FIG. 15shows third spool assembly 36 c coupled to docking station 56 c withoutthe presence of the other spool assemblies 36 a and 36 b, by way ofillustration and not limitation.

FIG. 16 shows a system 600 for repairing malpositioning of the wall ofthe ventricle of the patient, in accordance with respective applicationsof the present invention. System 600 treats a weakened state of heart 2in which the wall of the left ventricle is malpositioned and weakened.As a result of the malpositioning of the wall of the heart, leaflets 12and 14 of mitral valve 8 are malpositioned and are distanced from oneanother (not shown). In order to treat the malpositioning of the heartwall and thereby of leaflets 12 and 14, spool assembly 36 is implantedat a first portion 420 of heart tissue which faces and surrounds theleft ventricle of heart 2. First implantation site 5 thus comprisesfirst portion 420 of heart tissue. It is to be noted that firstimplantation site 5 is at the base of the papillary muscle by way ofillustration and not limitation, and that first implantation site 5 maybe at a portion of the wall of the heart in a vicinity of the apex ofthe heart, or at papillary muscle 4. For some applications in whichsystem 600 treats malpositioning of the heart, docking assembly 350 andspool assembly 36 are implanted externally to the ventricle, and chord74 extends through cardiac tissue and into the ventricle towardimplantation site 7.

Spool assembly 36 is implanted via docking assembly 150 at site 5 in amanner as described hereinabove with reference to FIGS. 3-6. As shown,the free ends of chord 74 are coupled to a second portion 422 of hearttissue which faces and surrounds the left ventricle of heart 2. Secondimplantation site 7 thus comprises second portion 422 of heart tissue,e.g., at the septum, by way of illustration and not limitation. The freeends of longitudinal chord 74 are coupled to the heart tissue using anysuitable attachment means 602, e.g., sutures, knotting, or tissueanchors such as helical anchors. Spool 46 of adjustment mechanism 43 isrotated, as described hereinabove, thereby pulling tight chord 74 andthereby reducing a length of chord 74 between first and secondimplantation sites 5 and 7. In response to the pulling of chord 74,first and second portions 420 and 422 of the heart tissue are pulledtoward one another, and a length of chord 74 is adjusted. Consequently,the dimensions of the heart wall are restored to physiologicaldimensions, and leaflets 12 and 14 are drawn toward one another.

FIG. 17 shows a system 610 for adjusting both malpositioning of a heartwall of heart 2, and a relative disposition of leaflet 12, in accordancewith some applications of the present invention.Multiple-docking-station assembly 350 is implanted at implantation site5, i.e., a portion of tissue of a heart wall of heart 2 in a vicinity ofthe apex of heart 2. It is to be noted that implantation site 5 mayinclude any portion of tissue of heart 2, e.g., a portion of tissue atthe base of papillary muscle 4, a portion of tissue of papillary muscle4, or a portion of the free wall of the ventricle. As describedhereinabove, first spool assembly 36 a is coupled to docking station 56a and adjusts a length of chord 74 aa in order to adjust a distancebetween implantation sites 5 and 7. Second spool assembly 36 b iscoupled to docking station 56 b and adjusts a length of chord 74 bb inorder to adjust a distance between implantation site 5 a thirdimplantation site 9 (e.g., leaflet 12, as shown). As describedhereinabove, chords 74 aa and 74 bb may be adjusted simultaneously orsequentially. Following the adjusting, implantation sites 7 and 9 aredrawn toward multiple-docking-station assembly 350 at implantation site5. Consequently, the dimensions of the heart wall are restored tophysiological dimensions, and leaflets 12 and 14 are drawn toward oneanother. It is to be noted that although leaflet-engaging element 72 isshown as engaging only leaflet 12, the scope of the present inventionincludes the engaging of both leaflets 12 and 14 by leaflet-engagingelement 72.

It is to be further noted that the scope of the present inventionincludes the coupling of a third spool assembly to docking station 56 ccoupled to chord 74 c. For such applications, the free end of chord 74 cmay be coupled to a different portion of cardiac tissue, e.g., leaflet14.

FIG. 18 is a schematic illustration of a system 800 for adjusting adistance between two portions of a heart wall of the left ventricle ofthe patient, in accordance with some applications of the presentinvention. System 800 comprises a tensioning device 802 coupled at afirst end thereof to spool assembly 36 at docking assembly 150. In amanner as described hereinabove, spool assembly 36 is implanted at firstimplantation site 5 in a first portion of tissue of the heart wall thatfaces and surrounds the ventricular lumen. The free end of tensioningdevice 802 is attached at second implantation site 7 to a second portionof tissue of the heart wall that faces and surrounds the ventricularlumen. The free end of tensioning device 802 is implanted in hearttissue using a helical anchor by way of illustration and not limitation.For example, the free end of tensioning device 802 may be coupled tosecond implantation site 7 using sutures, knots, or any tissue anchorknown in the art.

Tensioning device 802 comprises a flexible material, e.g., ePTFE ornitinol, and is shaped to define a coiled portion 806 that has a lengthof between 20 mm and 50 mm and a diameter of between 0.5 mm and 3.0 mm.Tensioning device 802 comprises respective wire/suture portions 804 oneither side of coiled portion 806. For such an application, the sutureportion 804 that is between spool assembly 36 and coiled portion 806comprises portions 74 a and 74 b of chord 74.

As described hereinabove, spool 46 of adjustment mechanism 43 is rotatedin order to adjust a distance between first and second implantationsites 5 and 7. As spool 46 is rotated in a first direction thereof,successive portions of chord 74 of suture portion 804 that is disposedadjacently to spool assembly 36 are wrapped around spool 46. Tensioningdevice 802 is tightened and shortened in response to the wrapping ofportion 804 around spool 46. As device 802 is tightened, a force isapplied to coiled portion 806 of tensioning device 802. Coiled portion806 applies a supplemental puling force to help pull the opposing firstand second portions of the ventricle wall toward one another.Consequently, the dimensions of the heart wall are restored tophysiological dimensions, and leaflets 12 and 14 are drawn toward oneanother.

Reference is made to FIGS. 16-18. It is to be noted that the scope ofthe present invention includes the use of systems 600, 610, and 800 foradjusting a distance between any two portions of the heart and not justopposing portions, as described hereinabove. For example, first andsecond implantation sites 5 and 7 may be on the same side, e.g., theseptum, of the wall of the heart.

Reference is now made to FIG. 19, which is a schematic illustration of asystem 960 for drawing together leaflets 12 and 14 of mitral valve 8 ofthe patient, in accordance with some applications of the presentinvention. Spool assembly 36 is implanted via docking assembly 150 infirst implantation site 5 at papillary muscle 4 of the left ventricle byway of illustration and not limitation. For example, spool assembly 36may be implanted in a portion of the heart wall of the ventricle, e.g.,the base of the papillary muscle. First and second portions 74 a and 74b of chord 74 are coupled (e.g., sutured, anchored, clipped, or lockedin place with a crimping bead 918, as shown) to leaflet 12 at animplantation site 902. It is to be noted that portions 74 a and 74 b maybe coupled to leaflets 12 and 14, respectively, using leaflet-engagingelements 72 as described hereinabove.

As described hereinabove, spool 46 of adjustment mechanism 43 is rotatedin order to adjust a length of portions 74 a and 74 b of chord 74.Portions 74 a and 74 b are pulled tight in response to rotation of spool46 in a first direction thereof. In response to the pulling of portions74 a and 74 b, leaflets 12 and 14 are pulled toward one another in orderto restore coaptation to valve 8.

It is to be noted that system 960 may be used on the tricuspid valve.

System 960 further comprises at least one bead 940 that is threaded overportions 74 a and 74 b of chord 74. The surgeon adjusts the position ofthe bead along the portions 74 a and 74 b in order to set the degree towhich portions 74 a and 74 b are free to move with respect to oneanother. In general, as bead 940 is positioned closer to valve 8,portions 74 a and 74 b are more constrained in their motion with respectto one another, and leaflets 12 and 14 are drawn closer together. Forsome applications of the present invention, bead 940 comprises afixation mechanism (e.g., a crimping mechanism), which is configured tofix the bead to portions 74 a and 74 b of chord 74 once bead 940 hasbeen positioned at a desire location along portions 74 a and 74 b.

FIG. 20 shows a system 980 that is similar to system 960 as describedwith reference to FIG. 19, with the exception that bead 940 is pulled bythe operating physician to the ventricular surface of a middle portionof valve 8, in accordance with some applications of the presentinvention. Such pulling of bead 940 to the ventricular surface creates abridge between leaflets 12 and 14, e.g., as an Alfieri stitch, oredge-to-edge repair. Portions 74 a and 74 b are then adjusted in orderto pull together the middle portion of mitral valve 8, as shown inSection A-A. The firm coupling of leaflets 12 and 14 prevents prolapsingof leaflets 12 and 14, facilitates coaptation of leaflets 12 and 14, andcreates orifices 962 and 964 (section A-A) in mitral valve 8 so as tofacilitate blood flow from the atrium to the ventricle. Additionally,the adjusting of portions 74 a and 74 b of chord 74 draws downwardleaflets 12 and 14 and adjusts chord 74 such that it functions as anartificial chordea tendinea.

Reference is now made to FIGS. 19 and 20. It is to be noted thatalthough docking assembly 150 is shown, multiple-docking-stationassembly 350 as described hereinabove, may be implanted at implantationsite 5. For such an application, two or more spool assemblies 36 may becoupled to multiple-docking-station assembly 350, and any number ofchords 74 extending from each spool assembly 36 may be coupled toleaflets 12 and 14 at any suitable location thereof. The lengths ofchords 74 are then adjusted by spool assemblies 36 in order to pullleaflets 12 and 14 together.

Reference is now made to FIG. 21, which is a schematic illustration of asystem 1000 comprising docking assembly 150 for implantation at animplantation site 5 a that includes an annulus 1100 of a cardiac valveof the patient, in accordance with some applications of the presentinvention. It is to be noted that the mitral valve is shown by way ofillustration and not limitation, and that system 1000 can be used on anyother cardiac valve of the patient, e.g., the tricuspid valve, thepulmonary valve, and the aortic valve. System 1000 comprises dockingassembly 150 and the guide member coupled thereto (e.g., guide wire 40),as described hereinabove with reference to FIGS. 1-2.

For some applications in which docking assembly 150 is implanted at theannulus of the cardiac valve, implant 42 configured to be coupled todocking assembly 150 comprises an annuloplasty ring structure (e.g., afull annuloplasty ring or a partial annuloplasty ring). Typically, theannuloplasty ring structure comprises adjustment mechanism 43. It is tobe noted, however, that the annuloplasty ring structure configured to becoupled to docking assembly 150 may be provided independently ofadjustment mechanism 43. That is, any suitable annuloplasty ringstructure may be coupled to docking assembly 150. For such applications,the annuloplasty ring structure is slid along guide wire 40 towarddocking assembly 150.

For other applications in which docking assembly 150 is implanted at theannulus of the cardiac valve, implant 42 configured to be coupled todocking assembly 150 comprises a prosthetic valve or a support structurefor coupling a prosthetic valve thereto. For some applications, thesupport structure comprises adjustment mechanism 43. It is to be noted,however, that the support structure configured to be coupled to dockingassembly 150 may be provided independently of adjustment mechanism 43.That is, any suitable support structure or prosthetic valve may becoupled to docking assembly 150. For such applications, the supportstructure or prosthetic valve is slid along guide wire 40 toward dockingassembly 150.

Reference is made to FIG. 22, which is a schematic illustration ofsystem 1000 being used to facilitate implantation of implant 42,comprising an annuloplasty ring 1120, at annulus 1100 of a cardiacvalve, in accordance with some applications of the invention. It is tobe noted that the mitral valve is shown by way of illustration and notlimitation, and that system 1000 can be used on any other cardiac valveof the patient, e.g., the tricuspid valve, the pulmonary valve, and theaortic valve. It is to be noted that annuloplasty ring 1120 is shown asa partial annuloplasty ring by way of illustration and not limitation,and that annuloplasty ring 1120 may comprise a full annuloplasty ring.Docking assembly 150 is advanced to the annulus, and tissue anchor 50 isanchored to tissue in the vicinity of the annulus (e.g., to tissue ofthe annulus). For applications in which tissue anchor 50 comprises ahelical tissue anchor, the anchor is typically coupled to the tissue byrotating the entire docking assembly 150 (e.g., using a delivery tool,such as delivery tool 30, described hereinabove with reference to FIGS.1-2, mutatis mutandis). As described hereinabove (e.g., with referenceto FIG. 2), a guide member (e.g., guide wire 40) is left behind, coupledto docking assembly 150 (e.g., to docking station 56 thereof).

Subsequently, and as shown in FIG. 22, annuloplasty ring 1120 isadvanced along guide wire 40 toward annulus 1100 and docking assembly150. Typically, annuloplasty ring 1120 is shaped to define a channeltherethrough (e.g., between an upper surface and a lower surface of theannuloplasty ring), within which guide wire 40 is configured to bedisposed, and the annuloplasty ring is slid over the guide wire. Forsome applications, and as shown in FIG. 22, annuloplasty ring 1120comprises an adjustable annuloplasty ring that comprises an adjustmentmechanism 1143, configured to adjust the annuloplasty ring (e.g., asdescribed hereinbelow). For some such applications, adjustment mechanism1143 is shaped to define the channel within which guide wire 40 isconfigured to be disposed.

Typically, adjustment mechanism 1143 comprises adjustment mechanism 43and/or spool assembly 36, described hereinabove. Further typically,annuloplasty ring 1120 comprises a sleeve 1126 that defines a lumentherethrough, and a flexible longitudinal member 1130, disposed at leastin part within the lumen of the sleeve, and adjustment mechanism 1143 isconfigured to adjust the length of the sleeve (e.g., the diameter of theannuloplasty ring) by adjusting the length of the flexible longitudinalmember. For some applications, flexible longitudinal member 1130 iscoupled to and adjusted by adjustment mechanism 1143, in a similarmanner to that in which chord 74 is coupled to and adjusted byadjustment mechanism 43, described hereinabove.

Once annuloplasty ring 1120 reaches docking assembly 150, theannuloplasty ring is locked to the docking assembly as describedhereinabove (e.g., with reference to FIG. 6), mutatis mutandis. That is,a coupling defined by the annuloplasty ring is locked to a couplingdefined by the docking assembly, typically by the couplings being pushedtoward and/or into each other.

For some applications, additional anchors are subsequently used tocouple other portions of annuloplasty ring 1120 to other portions oftissue in the vicinity of annulus 1100. For example, and as shown inFIG. 22, annuloplasty ring 1120 may comprise a partial annuloplasty ringthat comprises sleeve 1126, and successive portions of sleeve 1126 maybe placed on annulus 1100, and anchored to the annulus using a pluralityof successive anchors 1140, deployed using a deployment manipulator1142, from within the lumen of the sleeve, through the wall of thesleeve, and into the annulus. For some such applications, dockingassembly 150 is used to guide and anchor a first portion of theannuloplasty ring to a first anchoring site of the annulus, andsuccessive anchors 1140 are subsequently used to anchor other portionsof the annuloplasty ring.

For some applications, a plurality of docking assemblies 150 and aplurality of guide wires 40 are used to advance and lock a plurality ofportions of annuloplasty ring 1120 to the tissue. For some suchapplications, annuloplasty ring comprises a plurality of adjustmentmechanisms 1143 disposed around the length of sleeve 1126 (e.g., toadjust the length of different portions of the sleeve), and each of theadjustment mechanisms is advanced over a respective guide wire 40 andlocked to a respective docking station of a respective docking assembly.

It is to be noted that the locking of annuloplasty ring 1120 to dockingassembly 150 is performed suturelessly.

For some applications of the present invention, systems 20, 220, 320,600, 610, 800, 960, 980, and 1000 are used to treat an atrioventricularvalve other than the mitral valve, i.e., the tricuspid valve. For theseapplications, systems 20, 220, 320, 600, 610, 800, 960, 980, and 1000described hereinabove as being placed in the left ventricle are insteadplaced in the right ventricle.

It is to be noted that the scope of the present invention includes theuse of systems 20, 220, 320, 600, 610, 800, 960, 980, and 1000 on othercardiac valves, such as the pulmonary valve or the aortic valve.

It is to be further noted that the scope of the present inventionincludes the use of systems 20, 220, 320, 600, 610, 800, 960, 980, and1000 on other tissue other than cardiac tissue, e.g., gastric tissue orany other suitable tissue or organ.

For some applications, techniques described herein are practiced incombination with techniques described in one or more of the referencescited in the Background section of the present patent application.

Additionally, the scope of the present invention includes applicationsdescribed in the following applications, which are incorporated hereinby reference. In an application, techniques and apparatus described inone or more of the following applications are combined with techniquesand apparatus described herein:

-   -   PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral        Valve treatment techniques,” filed Mar. 15, 2006;    -   U.S. Provisional Patent Application 60/873,075 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;    -   U.S. Provisional Patent Application 60/902,146 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed on Feb. 16,        2007;    -   U.S. Provisional Patent Application 61/001,013 to Gross et al.,        entitled, “Segmented ring placement,” filed Oct. 29, 2007;    -   PCT Patent Application PCT/IL07/001503 to Gross et al.,        entitled, “Segmented ring placement,” filed on Dec. 5, 2007;    -   U.S. patent application Ser. No. 11/950,930 to Gross et al.,        entitled, “Segmented ring placement,” filed on Dec. 5, 2007,        which published as US Patent Application Publication        2008/0262609;    -   U.S. Provisional Patent Application 61/132,295 to Gross et al.,        entitled, “Annuloplasty devices and methods of delivery        therefor,” filed on Jun. 16, 2008;    -   U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled,        “Adjustable partial annuloplasty ring and mechanism therefor,”        filed on Dec. 22, 2008, which published as 2010/0161047;    -   U.S. Provisional Patent Application 61/207,908 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed on Feb. 17, 2009;    -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which published as        2010/0161041;    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009, which published as 2010/0286767;    -   PCT Patent Application PCT/IL2009/000593 to Gross et al.,        entitled,    -   “Annuloplasty devices and methods of delivery therefor,” filed        on Jun. 15, 2009, which published as WO 10/004546;    -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        Aug. 27, 2009, which published as 2010/0161042;    -   U.S. patent application Ser. No. 12/608,316 to Miller et al.,        entitled, “Tissue anchor for annuloplasty ring,” filed on Oct.        29, 2009, which published as 2011/0106247;    -   PCT Patent Application PCT/IL2009/001209 to Cabiri et al.,        entitled, “Adjustable annuloplasty devices and mechanisms        therefor,” filed on Dec. 22, 2009, which published as WO        10/073246;    -   U.S. patent application Ser. No. 12/689,635 to Zipory et al.,        entitled, “Over-wire rotation tool,” filed on Jan. 19, 2010,        which published as 2010/0280604;    -   U.S. patent application Ser. No. 12/689,693 to Hammer et al.,        entitled, “Application Deployment techniques for annuloplasty        ring,” filed on Jan. 19, 2010, which published as 2010/0280605;    -   U.S. patent application Ser. No. 12/706,868 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed on Feb. 17, 2010,        which published as 2010/0211166; and/or    -   U.S. patent application Ser. No. 12/795,026 to Miller et al.,        entitled, “Apparatus for guide-wire based advancement of a        rotation assembly,” filed on Jun. 7, 2010, which published as        2011/0106245.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1-70. (canceled)
 71. Apparatus for use with a heart of a subject, theapparatus comprising: a tissue-engaging element having a distal portionconfigured to engage a portion of tissue of the heart; a guide memberreversibly coupled to the tissue-engaging element; an artificial chordatendinea having a distal end and a proximal end, at least the distal endbeing slidably coupled to the guide member; and a tool, slidable alongthe guide member distally toward the tissue-engaging element while (i)the tool is coupled to at least the distal end of the chorda, and (ii)the guide member is coupled to the tissue-engaging element, such thatsliding of the tool along the guide member distally toward thetissue-engaging element while (i) the tool is coupled to at least thedistal end of the chorda, and (ii) the guide member is coupled to thetissue-engaging element, slides at least the distal end of the chordatoward the tissue-engaging element.
 72. The apparatus according to claim71, wherein the tool is configured to couple the distal end of thechorda to the tissue-engaging element.
 73. The apparatus according toclaim 71, wherein the tool is configured to decouple the guide memberfrom the tissue-engaging element.
 74. The apparatus according to claim71, further comprising a cap that is shaped to define an opening throughwhich the guide member is slidable, wherein at least the distal end ofthe chorda is slidably coupled to the guide member via the cap.
 75. Amethod for use with a heart of a subject, the method comprising:advancing, into the heart, a tissue-engaging element coupled to a guidemember; coupling the tissue-engaging element to a portion of tissue ofthe heart; sliding at least a distal portion of an artificial chordatendinea distally along the guide member toward the tissue-engagingelement; and coupling the distal portion of the chorda to thetissue-engaging element.
 76. The method according to claim 75, furthercomprising decoupling the guide member from the tissue-engaging elementwhile the chorda remains coupled to the tissue-engaging element.
 77. Themethod according to claim 75, wherein the portion of the tissue of theheart is a portion of a papillary muscle of the heart, and whereincoupling the tissue-engaging element to the portion of tissue of theheart comprises coupling the tissue-engaging element to the portion ofthe papillary muscle.
 78. The method according to claim 75, wherein theportion of tissue of the heart faces a ventricle of the heart, andwherein coupling the tissue-engaging element to the portion of tissue ofthe heart comprises coupling the tissue-engaging element to the portionof tissue that faces the ventricle.